Journal article
Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer
Cancer medicine (Malden, MA), Vol.14(15), e71117
08/2025
DOI: 10.1002/cam4.71117
PMCID: PMC12316815
PMID: 40751295
Appears in UI Libraries Support Open Access
Abstract
Aromatase inhibitor (AI) therapy reduces breast cancer recurrence risk. However, some patients stop treatment early because of AI-associated musculoskeletal symptoms (AIMSS). AIMSS is due in part to systemic inflammation. Cannabidiol (CBD) has anti-nociceptive and anti-inflammatory properties, making it a potential treatment option for AIMSS.
Women with stage 0-3 hormone receptor-positive breast cancer experiencing AIMSS enrolled in this phase 2 clinical trial. Patients received CBD (Epidiolex), titrated over 4 weeks to 100 mg BID, for a total of 15 weeks. Patient-reported outcomes were collected serially. The primary endpoint was the number of patients with at least a 2-point reduction in worst pain from baseline to 15 weeks. Statistical analysis was completed using paired t-tests and linear mixed models.
Of 39 eligible patients, 28 completed protocol-directed study treatment. Eleven discontinued treatment due to toxicity (n = 5) or per patient preference (n = 6). Seventeen of 39 patients met the primary endpoint (43.6%, 95% CI [28%, 60%]). Worst pain improved 0.13 per week of treatment (p < 0.001) for all patients; average improvement in worst pain was 1.95 points at the end of 15 weeks. Of the 28 patients who completed the study, average reduction in worst pain was 2.36 points (95% CI [-3.22, -1.49]) between baseline and Week 15.
Treatment with CBD was safe, tolerable, and associated with improvement in joint pain for a subset of patients. Additional studies are needed to further understand the impact of CBD on AIMSS and which patients are most likely to benefit from CBD treatment.
www.
gov: NCT04754399.
Details
- Title: Subtitle
- Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer
- Creators
- Nicole M G Fleege - University of Michigan Medical SchoolElise A Miller - University of MichiganKelley M Kidwell - University of MichiganZeb R Zacharias - University of Iowa Holden Comprehensive Cancer CenterJon Houtman - University of Iowa Holden Comprehensive Cancer CenterKelly Scheu - University of MichiganKathleen Kemmer - University of Michigan Medical SchoolKevin F Boehnke - University of Michigan Medical SchoolN Lynn Henry - University of Michigan Medical School
- Resource Type
- Journal article
- Publication Details
- Cancer medicine (Malden, MA), Vol.14(15), e71117
- DOI
- 10.1002/cam4.71117
- PMID
- 40751295
- PMCID
- PMC12316815
- NLM abbreviation
- Cancer Med
- ISSN
- 2045-7634
- eISSN
- 2045-7634
- Publisher
- Wiley
- Grant note
- Rising Tide Foundation for Clinical Cancer Research P30CA086862 / NIH HHS Conquer Cancer Foundation UM1TR004404 / NIH HHS
- Language
- English
- Date published
- 08/2025
- Academic Unit
- Microbiology and Immunology; Holden Comprehensive Cancer Center; Internal Medicine
- Record Identifier
- 9984927088002771
Metrics
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